The Case Studies I course is designed to utilize a studio process to enrich early-career research. Studios are structured, dynamic sessions which bring together relevant research experts with the purpose of enhancing research quality, improving funding success, fostering advances in clinical practice and improvements in patient health, increasing publications, and generating new hypotheses. Participants include 2 to 6 experienced faculty, your mentor, your MSCI peers, and the MSCI program directors. You choose the most appropriate studio depending on the stage of your research: hypothesis generation, aims, study design, implementation, analysis and interpretation, translation, manuscript development, or grant development. Presentations should be conducted as if presenting at a research conference. Attendance at peers’ studios is expected as it will foster critical thinking from an interdisciplinary approach, collegiality, and collaboration.

Fall, Spring, Summer [1]

The Clinical Research Skills seminar offers basic instruction and practical advice on commonly encountered clinical research topics. Sessions are typically demonstration-oriented and provide an informal setting to learn new skills. Participants will also learn effective communication of research findings and collaboration with other researchers. Upon completion of the course, participants will have a broad understanding of the clinical research process and VICTR resources.

Fall, Spring, Summer [1]

This seminar series, conducted in conjunction with the office of Clinical and Translational Scientist Development, features two pathways based on the trainee’s current career stage: Edge – Post-doctoral MD and PhD investigators completing training and establishing careers in clinical and translational research; Newman Society – Junior faculty members pursuing a career as a physician-scientist, biomedical scientist, or as a clinical educator with significant research involvement. Topics of discussion will include academic ‘rules of the road’, time management, promotion/tenure issues, publication compliance, independence, scientific branding, grants management, and overall program evaluation. Trainees will also submit a poster abstract to the annual Clinical and Translational Research Forum hosted in the fall. The seminars occur throughout the MSCI matriculation.

Fall, Spring [1]

Scholars will participate in this course throughout the first and second years of the MSCI program. The Master’s Research course, along with the Case Studies series, is designed to guide trainees to the successful completion of the Master’s Final project. All scholars are required to spend a minimum of 75% time in research activities, which include didactic coursework and activities within the mentor’s lab.

Fall, Spring, Summer [2-3]

Scholars will participate in this course throughout the first and second years of the MSCI program. The Master’s Research course, along with the Case Studies series, is designed to guide trainees to the successful completion of the Master’s Final project. All scholars are required to spend a minimum of 75% time in research activities, which include didactic coursework and activities within the mentor’s lab.

Fall, Spring, Summer [3]

Scholars will participate in this course throughout the first and second years of the MSCI program. The Master’s Research course, along with the Case Studies series, is designed to guide trainees to the successful completion of the Master’s Final project. All scholars are required to spend a minimum of 75% time in research activities, which include didactic coursework and activities within the mentor’s lab.

Fall, Spring, Summer [3]

The Case Studies II course provides an opportunity to present and discuss the progress and results of the scholar’s primary MSCI project. In accomplishing this goal, the course utilizes a studio process and/or presentation format. You choose the most appropriate format depending on the stage of your research: presentation, manuscript studio, data analysis studio, or grant review studio. Studios will be conducted in the same manner as in Case Studies I. Presentations should be first-authored at a research conference. Attendance at peers’ studios is expected as it will foster critical thinking from an interdisciplinary approach, collegiality, and collaboration.

Fall, Spring, Summer [1]

Scholars approved for the part-time track will participate in this course at the end of their MSCI program of study. The three-part Master’s Capstone series, along with the Case Studies series, is an integrated clinical or translational research project that spans the entire curriculum and culminates with the successful completion of the Master’s Final Project. Based on the trainee’s stated personal career objectives, the capstone project will afford the learner the flexibility to complete a thesis, a publishable first-author manuscript, or a grant application. This course may be taken concurrently with MSCI 5005 Case Studies in Clinical Investigation I.

Fall, Spring, Summer [2-3]

Scholars approved for the part-time track will participate in this course at the end of their MSCI program of study. The three-part Master’s Capstone series, along with the Case Studies series, is an integrated clinical or translational research project that spans the entire curriculum and culminates with the successful completion of the Master’s Final Project. Based on the trainee’s stated personal career objectives, the capstone project will afford the learner the flexibility to complete a thesis, a publishable first-author manuscript, or a grant application. This course may be taken concurrently with MSCI 5024 Case Studies in Clinical Investigation II.

Fall, Spring, Summer [3]

Scholars approved for the part-time track will participate in this course at the end of their MSCI program of study. The three-part Master’s Capstone series, along with the Case Studies series, is an integrated clinical or translational research project that spans the entire curriculum and culminates with the successful completion of the Master’s Final Project. Based on the trainee’s stated personal career objectives, the capstone project will afford the learner the flexibility to complete a thesis, a publishable first-author manuscript, or a grant application. This course may be taken concurrently with MSCI 5024 Case Studies in Clinical Investigation II.

Fall, Spring, Summer [3]

This is a comprehensive course that aims to equip medical professionals with the necessary statistical knowledge to interpret clinical data analysis and critically review clinical research. This course covers a wide range of topics, including descriptive statistics, probability distributions, statistical power and sample size, hypothesis testing, and regression analysis. Special topics (e.g., Bayesian methods, meta-analysis) may be covered. The course is designed to be accessible to anyone with a basic understanding of mathematics and no prior experience in statistics. By the end of this course, participants will have a strong foundation in biostatistics that will enable them to make informed decisions based on clinical data.

Fall [3]

The goal of this course is to teach clinical investigators the scientific writing and communication skills necessary for a productive, successful, and impactful scientific research career.

Fall [2]

This course is designed to teach important concepts related to research data planning, collection, storage, and dissemination. Instructional material will cover best-practice guidelines for 1) investigator-initiated & sponsored research studies, 2) single- & multi-center studies, and 3) prospective data collection & secondary-reuse of clinical data for purposes of research. The curriculum will balance theoretical guidelines with the use of practical tools designed to assist in planning and conducting research. Real-world research examples, problem-solving exercises, and hands-on training will ensure students are comfortable with all concepts.

Spring [1]

The main goal of this course is to provide an up-to-date perspective in genomics as it applies to clinical practice and medical research and thus to enhance knowledge and skills in this rapidly evolving field. This course is designed to give physician and life-scientist trainees an overview of genomic medicine and how best to utilize it in both clinical practice and research projects. The course will introduce students to key concepts in genetics and how these concepts affect genomic data interpretation and study design. Students will learn about a number of approaches that can be used to biologically test these data. The course format will be a mix of interconnected lectures, hands-on workshops, supplemented by online training modules.

Spring [3]

The primary focus of Biostatistics II is the multivariable regression model which is the fundamental tool that researchers use for prediction, effect estimation, and hypothesis testing. This course covers the most commonly used regression models (linear, logistic, ordinal, time-to-event, and serial) plus general methods applicable to all regression models such as restricted cubic splines, bootstrapping, multiple imputations for missing data, model diagnostics, and validation. There is an emphasis on aspects related to clinical and translational study design.

Spring [4]

This course is designed to teach important concepts related to research data planning, collection, storage, and dissemination. Instructional material will cover best-practice guidelines for 1) investigator-initiated & sponsored research studies, 2) single- & multi-center studies, and 3) prospective data collection & secondary-reuse of clinical data for purposes of research. The curriculum will balance theoretical guidelines with the use of practical tools designed to assist in planning and conducting research. Real-world research examples, problem-solving exercises, and hands-on training will ensure students are comfortable with all concepts.

Spring [1]

The Case Studies I course is designed to utilize a studio process to enrich early-career research. Studios are structured, dynamic sessions which bring together relevant research experts with the purpose of enhancing research quality, improving funding success, fostering advances in clinical practice and improvements in patient health, increasing publications, and generating new hypotheses. Participants include 2 to 6 experienced faculty, your mentor, your MSCI peers, and the MSCI program directors. You choose the most appropriate studio depending on the stage of your research: hypothesis generation, aims, study design, implementation, analysis and interpretation, translation, manuscript development, or grant development. Presentations should be conducted as if presenting at a research conference. Attendance at peers’ studios is expected as it will foster critical thinking from an interdisciplinary approach, collegiality, and collaboration.

Fall, Spring, Summer [1]

The Clinical Research Skills seminar offers basic instruction and practical advice on commonly encountered clinical research topics. Sessions are typically demonstration-oriented and provide an informal setting to learn new skills. Participants will also learn effective communication of research findings and collaboration with other researchers. Upon completion of the course, participants will have a broad understanding of the clinical research process and VICTR resources.

Fall, Spring, Summer [1]

This seminar series, conducted in conjunction with the office of Clinical and Translational Scientist Development, features two pathways based on the trainee’s current career stage: Edge – Post-doctoral MD and PhD investigators completing training and establishing careers in clinical and translational research; Newman Society – Junior faculty members pursuing a career as a physician-scientist, biomedical scientist, or as a clinical educator with significant research involvement. Topics of discussion will include academic ‘rules of the road’, time management, promotion/tenure issues, publication compliance, independence, scientific branding, grants management, and overall program evaluation. Trainees will also submit a poster abstract to the annual Clinical and Translational Research Forum hosted in the fall. The seminars occur throughout the MSCI matriculation.

Fall, Spring [1]

Scholars will participate in this course throughout the first and second years of the MSCI program. The Master’s Research course, along with the Case Studies series, is designed to guide early-career scholars to the successful completion of the Master’s Final project. All scholars are required to spend a minimum of 75% time in research activities, which include didactic coursework and activities within the mentor’s lab.

Fall, Spring, Summer [2-3]

Scholars will participate in this course throughout the first and second years of the MSCI program. The Master’s Research course, along with the Case Studies series, is designed to guide scholars to the successful completion of the Master’s Final project. All scholars are required to spend a minimum of 75% time in research activities, which include didactic coursework and activities within the mentor’s lab.

Fall, Spring, Summer [3]

Scholars will participate in this course throughout the first and second years of the MSCI program. The Master’s Research course, along with the Case Studies series, is designed to guide early-career scholars to the successful completion of the Master’s Final project. All trainees are required to spend a minimum of 75% time in research activities, which include didactic coursework and activities within the mentor’s lab.

Fall, Spring, Summer [3]

The Case Studies II course provides an opportunity to present and discuss the progress and results of the trainees’ primary MSCI project. In accomplishing this goal, the course utilizes a studio process and/or presentation format. You choose the most appropriate format depending on the stage of your research: presentation, manuscript studio, data analysis studio, or grant review studio. Studios will be conducted in the same manner as in Case Studies I. Presentations should be first-authored at a research conference. Attendance at peers’ studios is expected as it will foster critical thinking from an interdisciplinary approach, collegiality, and collaboration.

Fall, Spring, Summer [1]

Scholars approved for the part-time track will participate in this course at the end of their MSCI program of study. The three-part Master’s Capstone series, along with the Case Studies series, is an integrated clinical or translational research project that spans the entire curriculum and culminates with the successful completion of the Master’s Final Project. Based on the trainee’s stated personal career objectives, the capstone project will afford the learner the flexibility to complete a thesis, a publishable first-author manuscript, or a grant application. This course may be taken concurrently with MSCI 5005 Case Studies in Clinical Investigation I.

Fall, Spring, Summer [2-3]

Scholars approved for the part-time track will participate in this course at the end of their MSCI program of study. The three-part Master’s Capstone series, along with the Case Studies series, is an integrated clinical or translational research project that spans the entire curriculum and culminates with the successful completion of the Master’s Final Project. Based on the trainee’s stated personal career objectives, the capstone project will afford the learner the flexibility to complete a thesis, a publishable first-author manuscript, or a grant application. This course may be taken concurrently with MSCI 5024 Case Studies in Clinical Investigation II.

Fall, Spring, Summer [3]

Scholars approved for the part-time track will participate in this course at the end of their MSCI program of study. The three-part Master’s Capstone series, along with the Case Studies series, is an integrated clinical or translational research project that spans the entire curriculum and culminates with the successful completion of the Master’s Final Project. Based on the trainee’s stated personal career objectives, the capstone project will afford the learner the flexibility to complete a thesis, a publishable first-author manuscript, or a grant application. This course may be taken concurrently with MSCI 5024 Case Studies in Clinical Investigation II.

Fall, Spring, Summer [3]

This is the first of the two core courses on biostatistics offered in the MSCI program. Students are introduced to basic concepts, terms and methods in statistics ranging from descriptive statistics and graphics to hypothesis testing. Simple linear regression will also be covered as a transition to Biostatistics II. R language will be used throughout the entire course. A pre-course R Boot Camp will be offered to prepare for the use of R studio. The course’s goal is to provide a statistical foundation for students to design clinical research studies including the choice of outcomes and exposures/independent variables and to independently perform basic statistical analysis not including confounding variables. The course will prepare students for the MSCI Biostatistics II core course.

Fall [4]

This seminar styled course is designed to provide an overview of the drug and device development process and will include issues of drug discovery, pre-clinical drug development, Phase I through IV human testing, device development and the role of the FDA in regulatory affairs. Learning objectives will include: 1. To provide an overview of the drug development process from initial compound discovery, through clinical trials, to post-marketing issues; 2. To provide an overview of device development, and to contrast this to the process of drug development; 3. To provide some insight into the function of the Food & Drug Administration (FDA); 4. To discuss topical issues related to drugs, devices, and the FDA by using current events in the news.

Summer [3]

This course is a systematic examination of the ethical concepts and standards of responsible conduct of research in biomedical science and clinical investigation. Its aim is to provide students with a framework in which to anticipate, identify, analyze, navigate, and resolve ethical questions and conflicts in their professional work and support them in preparing for and conducting independent research and mentoring of others.

Primary objectives: Upon successfully completing this course, students will be able to:

1. Recognize, identify, and analyze questions central to issues in biomedical science and research using established ethical theories and frameworks, relevant professional standards, and law, regulation, and policy on human subjects research; animal research; conflict of interest; data collection, management, and sharing; authorship and publication; peer review; collaboration; and mentor-trainee relations;
2. Formulate recommendations for promoting responsible conduct and preventing and/or resolving ethical conflict in biomedical science and research, reflecting regulations, formal codes, professional standards, and ethical theories and frameworks as appropriate; and
3. Identify the appropriate institutional resources for addressing questions related to ethics and integrity in biomedical science and research in academic and nonacademic settings.

Summer [1]

The course will introduce the principles of designing and analysing evidence-based clinical and translational research studies. Additionally, the course will cover the concept of causation versus prediction, the design of clinical (epidemiological) research, disease frequency and association measures, validity issues including confounding, and the generalizability of research to practice. Subsequently, in more detail, the course addresses the design and analysis of diagnostic, prognostic, therapeutic (focusing on randomised trials), and etiologic (side effects) research.

Fall [4]

This course will provide an overview and introduction to the statistical programming software R. It will cover basic concepts and techniques including software installation and packages, data types and functions, and data importing, manipulation and cleaning. Subsequently, basic descriptive statistics and graphics will be reviewed.

Spring [1]

This course will cover design and data analysis for clinical trials in biomedical research. Primary topics include specification of study objectives, design options, ethical guidelines, randomization, blinding, sample size determination and power analysis, interim monitoring and data analysis appropriate for parallel, crossover, nested, factorial and group allocation designs. Other topics include the role of FDA in the drug approval process, adaptive trial designs, non-inferiority trials, and bio-equivalence trials. Emphasis is on the practical use of methods rather than formal statistical theory.

Fall [3]